Catalog Number

-

Brand Name

AEROBIKA Oscillating Positive Expiratory Pressure Therapy System

Version/Model Number

110501

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K123400,K123400,K123400,K123400,K123400

Product Code

BWF

Product Code Name

Spirometer, Therapeutic (Incentive)

Public Device Record Key

79a4d622-b208-4612-acb0-c7d38564946a

Public Version Date

June 22, 2021

Public Version Number

2

DI Record Publish Date

February 18, 2020

Package DI Number

10762860105017

Quantity per Package

10

Contains DI Package

00762860105010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-